Urinary Urge Incontinence Clinical Trial
Official title:
Double-Blind Randomized Controlled Trial of Extended Release Oxybutynin Versus Placebo in Women Receiving Posterior Tibial Nerve Stimulation for Treatment of Urgency Urinary Incontinence
This is a randomized double-blind placebo-controlled clinical trial of posterior tibial nerve
stimulation (PTNS) plus extended release oxybutynin versus PTNS alone (placebo pills) in
women undergoing treatment of urgency urinary incontinence (UUI).
The investigators hypothesize that combination therapy with PTNS and anticholinergic
medication will result in a significant incremental improvement in UUI symptoms over that
achieved with PTNS alone. In addition, the investigators hypothesize that the addition of
anticholinergics to PTNS will result in a greater improvement in patients' perception of
treatment response, symptom distress, and quality of life than PTNS alone.
Specific Aim 1: To compare the change, from baseline, in mean number of UUI episodes per day
using a 3-day bladder diary between PTNS plus anticholinergic medication versus PTNS plus
placebo in women undergoing treatment for UUI.
Specific Aim 2: To compare the change, from baseline, in a 24hr pad weight between PTNS plus
anticholinergic medication versus PTNS plus placebo.
Specific Aim 3: To compare subjective treatment response, symptoms distress, and quality of
life between PTNS plus anticholinergic medication versus PTNS plus placebo utilizing the
Patient Global Impression of Improvement (PGI-I) and the Overactive Bladder Questionnaire
Short Form (OABq-SF).
An interim analysis will be conducted by an independent entity after 50 participants have
completed the study protocol. A Data Safety Monitoring Board is not utilized because the
study utilizes FDA approved treatments for urgency urinary incontinence.
n/a
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